Gastric bypass system and method

ABSTRACT

A system and method for treating obesity including a first instrument containing a first magnet therein, the first instrument insertable into a stomach of a patient and the first magnet deployable into the stomach of the patient and having a first space. A second instrument contains a second magnet therein, the second instrument insertable into a bowel of a patient and the second magnet deployable into the bowel of the patient and having a second space. A stent is insertable into the first and second spaces to maintain an opening formed between the stomach and bowel.

This application claims priority from provisional application Ser. No.62/062,366, filed Oct. 10, 2014, the entire contents of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The application relates to system and method treating obesity, and, moreparticularly, to a system and method for performing gastric bypass.

2. Background of the Related Art

The incidence of obesity continues to increase worldwide. Obesity hasbeen defined in terms of a body mass index greater than 30, with bodymass index defined by weight in kilograms divided by the square of theheight in meters. (Overweight is defined as a body mass index of over25). Obesity can cause a number of serious health conditions such ashypertension, diabetes, certain forms of cancer, coronary arterydisease, stroke, congestive heart failure, and venous disease. Obesitycan also cause orthopedic problems, skin problems and respiratorydifficulties.

A variety of methods are currently being utilized to treat obesity. Ingeneral, these procedures fall into two categories: procedures whichrestrict food intake or procedures which alter the anatomy of the smallintestine or divert the peristalsis of a person's food intake past thesmall intestine to decrease caloric absorption.

Some methods are designed to reduce the stomach by partition or bypasssuch as by stapling or tying off portions of the large or smallintestine or stomach to reduce the amount of food desired by thepatient, and the amount absorbed by the intestinal tract. In gastricbanding, an adjustable band is placed externally of the stomach toconstrict a portion of the stomach. Such treatments are designed toreduce the caloric intake of the individual by more rapidly triggeringthe satiety impulse or limiting the amount of food the individual caningest. Complications can occur as the individual, due to the stomachrestriction, may not be intaking sufficient nutrients.

Laparoscopic methods of banding and vertical banded gastroplasty havebeen developed, which although provide the advantages of minimallyinvasive surgery compared to open surgery such as less trauma, lesshospital stay and faster recovery, are complicated to perform.

The need exists for an improved system and method for treating obesity.

SUMMARY OF THE INVENTION

The present invention advantageously provides a minimally invasivesystem and method for treating obesity.

In accordance with a first aspect, the present invention provides amethod for treating obesity comprising the steps of:

inserting first and second endoscopes, the first endoscope inserted intoa stomach of the patient and the second endoscope inserted into a bowelof a patient;

delivering a penetrating device to penetrate a wall of the stomach and awall of the bowel;

approximating the bowel and stomach;

deploying a first magnet in the stomach and a second magnet in thebowel;

creating an opening between the stomach and bowel; and

positioning a stent into the opening.

In some embodiments, the step of inserting a first endoscope into thestomach includes advancing the first endoscope transorally into thestomach.

In some embodiments, the method further includes the step of inserting aT-bar through the wall of the stomach and wall of the bowel and the stepof approximating the bowel and stomach includes the step of pulling theT-bar proximally.

In some embodiments, the first magnet is deployed from the firstendoscope and the second magnet is deployed from the second endoscope.In some embodiments, the first magnet has a first opening and the secondmagnet has a second opening, and the step of creating an opening betweenthe stomach and the bowel includes inserting a cutting instrumentthrough the first and second openings of the magnets. In someembodiments, the first magnet is retained in the first endoscope in asubstantially linear position and/or the second magnet is retained inthe second endoscope in a substantially linear position and the firstand/or second magnets move to a curved placement position afterdeployment from the respective endoscope.

In some embodiments, the first endoscope has a first channel to receivethe first magnet and a second channel to receive a device forapproximating the stomach and bowel, and the step of deploying the firstmagnet advances the first magnet from the first channel. The firstendoscope can have in some embodiments a third channel to receive thestent and the step of positioning the stent in the opening can includethe step of advancing the stent from the third channel.

The method can include the step of removing the first and secondendoscopes and closing off a portion of the stomach.

In accordance with another aspect of the present invention, a system fortreating obesity is provided comprising a first instrument containing afirst magnet therein, the first instrument insertable into a stomach ofa patient and the first magnet deployable into the stomach of thepatient and having a first space. A second instrument contains a secondmagnet therein, the second instrument insertable into a bowel of apatient and the second magnet deployable into the bowel of the patientand having a second space. A stent is insertable into the first andsecond spaces to maintain an opening formed between the stomach andbowel.

In some embodiments, the first magnet is retained in the firstinstrument in a substantially linear position in the deliveryconfiguration and has a curved placement configuration after deploymentfrom the first instrument. In some embodiments, the second magnet isretained in the second instrument in a substantially linear position inthe delivery configuration and has a curved placement configurationafter deployment from the second instrument.

In some embodiments, the stent has a first collapsed configuration whenpositioned in the first instrument and an expanded second position afterexposure from the first instrument.

In some embodiments, the first instrument has a first channel to receivethe first magnet and a second channel to receive a device forapproximating the stomach and bowel. In some embodiments, the firstinstrument has a third channel to receive the stent.

BRIEF DESCRIPTION OF THE DRAWINGS

So that those having ordinary skill in the art to which the subjectinvention appertains will more readily understand how to make and usethe surgical apparatus disclosed herein, preferred embodiments thereofwill be described in detail hereinbelow with reference to the drawings,wherein:

FIG. 1 is a perspective view of a first endoscopic instrument of thepresent invention configured for transoral insertion into the stomach ofa patient;

FIG. 2 is a perspective view showing the first endoscopic instrument ofFIG. 1 positioned in the stomach and a second endoscopic instrumentinserted in the bowel;

FIG. 3A is a front perspective view of the first endoscopic instrumentof FIG. 1;

FIG. 3B is a front perspective view of an alternate embodiment of thefirst endoscopic instrument of the present invention;

FIG. 4 is a perspective view of one of the magnets of the presentinvention in the elongated delivery configuration;

FIG. 5A is a perspective view of the magnet of FIG. 4 in a circularplacement configuration;

FIG. 5B is a perspective view of the magnet of FIG. 4 in an alternateC-shaped placement configuration;

FIGS. 6-20 illustrate the method of use of the system of the presentinvention wherein

FIG. 6 illustrates the second endoscopic instrument being inserted intothe bowel;

FIG. 7 illustrates the first endoscopic instrument being inserted intothe stomach via a transoral approach;

FIG. 8 illustrates a needle and T-bar delivery sheath being advancedfrom the first endoscopic instrument of FIG. 1 and further showing thesecond endoscopic instrument positioned in the bowel;

FIG. 9 is a view similar to FIG. 8 showing the needle advanced from thedelivery sheath to puncture the stomach wall;

FIG. 10 is a view similar to FIG. 9 illustrating the needle and T-barinserted through the stomach wall and into the bowel;

FIG. 11 is a view similar to FIG. 10 showing movement of the T-barproximally to approximate the stomach and bowel walls, and furthershowing initial deployment of the sheath containing the first magnet;

FIG. 12 is a view similar to FIG. 11 showing initial deployment of thefirst magnet from the sheath;

FIG. 13 is a view similar to FIG. 12 showing the first magnet fullyreleased from the first endoscopic instrument and positioned in thestomach, and further showing initial deployment from the secondendoscopic instrument the second sheath containing the second magnet;

FIG. 14 is a view similar to FIG. 13 showing initial deployment of thesecond magnet from the sheath;

FIG. 15 is a view similar to FIG. 14 showing the second magnet fullyreleased from the second endoscopic instrument and positioned in thebowel adjacent the bowel wall and the attraction of the second and firstmagnets to maintain the approximated position of the stomach and bowelwalls;

FIG. 16 is a view similar to FIG. 15 illustrating a puncturing deviceadvanced from the first endoscopic instrument and being inserted throughthe space (opening) in the first magnet;

FIG. 17 is a view similar to FIG. 16 showing initial deployment of asheath containing a stent from the first endoscopic instrument;

FIG. 18 is a view similar to FIG. 17 illustrating advancement of thestent sheath through the openings in the magnets;

FIG. 19 is a view similar to FIG. 18 illustrating placement of the stentin the space between the first and second magnets to maintain theopening between the stomach and bowel, and further showing the first andsecond endoscopic instruments being withdrawn; and

FIG. 20 illustrates the stent positioned in the stomach and bowel andthe endoscopic instruments removed.

FIG. 21 is a flow chart showing the procedural steps of the system ofthe present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to the drawings wherein like reference numerals identifysimilar structural features of the apparatus disclosed herein, there isillustrated in FIG. 1 a first endoscopic instrument, designatedgenerally by reference numeral 10. The first endoscopic instrument 10 ofthe system is configured to be inserted transorally into the stomach S,as shown in FIG. 2. A second endoscopic instrument 12 (FIG. 2) of thesystem is configured to be inserted into the bowel minimally invasivelythrough a port (not shown). The two instruments 10, 12 deliver first andsecond magnets, respectively, in performance of a gastric bypassprocedure explained in detail below.

As shown in FIG. 1, endoscopic instrument 10 is in the form of anendoscope having visualization capabilities. Endoscopic instrument 10has a flexible outer tube 14 and a handle 16 with optional access ports16 a, 16 b for insertion of instruments, insertion of fluid, and/oraspiration. Instruments inserted through the instrument 10 exit thedistal end 15. The flexible tube 14 is dimensioned for insertion throughthe natural opening of the mouth of the patient and through theesophagus into the patient's stomach to provide a minimally invasiveentry into the stomach. In alternate embodiments, the endoscopicinstrument 10 can be configured for insertion through an access port forminimally invasive entry into the stomach through a smallsurgeon-created opening.

The second endoscopic instrument 12, as shown in FIG. 8, has a distalend 13, imaging lens 17 a, an illumination lens or window 17 b for thelight delivery system, and a lumen 19 to receive a magnet deliverydevice 49 (FIG. 13) which contains a second magnet described below. Thesecond endoscopic instrument 12 can have flexible tube, handle andaccess ports as in the first endoscopic instrument 10.

Note the designations of “first” and “second” for the various componentsand instruments, e.g., endoscopic instruments and magnets, as usedherein are merely to identify the separate instruments and componentsand are not necessarily designated in the order of insertion. Forexample, the first endoscopic instrument can be inserted before or afterthe second endoscopic instrument, and the first magnet can be insertedbefore or after the second magnet.

As used herein, the term “proximal” denotes the portion of theinstrument closer to the user and the term “distal” denotes the portionof the instrument further from the user.

In the embodiment of FIG. 3A (and FIG. 8), the first endoscopicinstrument 10 has four working channels (lumens), an imaging lens 18 afor visualization of the surgical site and an illumination lens orwindow 18 b for the light delivery system for illuminating the surgicalsite. The four working channels or lumens are for the various componentsof the system which are deployable from the instrument 10 for performingthe gastric bypass procedure. More specifically, lumen 22 receives amagnet delivery device 40 for delivering a magnet 42 adjacent the innerstomach wall, lumen 24 receives a sheath 30 for delivering a needle 32and T-bar 34 for approximating the wall of the stomach and the wall ofthe bowel, lumen 26 receives a cutting instrument (device) 36 forcutting an opening between the deployed magnet 42 and a second magnetwhich is deployed in the bowel, and lumen 28 receives a stent sheath 50for delivery of a stent 52 in the openings in the magnets and throughthe approximated walls of the stomach and bowel to maintain the openingbetween the approximated stomach and bowel. The lumens 22, 24, 26, 28can be of various sizes and the instruments can be inserted throughlumens other than the particular lumen designated in FIG. 8, e.g.,sheath 30 can be inserted through lumen 28 and stent sheath 50 insertedthrough lumen 24.

In the alternate embodiment of FIG. 3B, the endoscopic instrument 60 hasfewer working channels (lumens), thereby reducing the overall diameterof the instrument 10. In this embodiment, the same channel can be usedto deploy several components of the system. For example, endoscopicinstrument 60 of this alternate embodiment has an imaging lens 62 and anillumination lens or window 64 for visualizing and illuminating thesurgical site as in the endoscopic instrument 10 of FIG. 3A. However,endoscopic instrument 60 has a lumen 66 for the needle 32 and T-bar 34and a lumen 68 for the magnet delivery device 40 and magnet 42. In thisembodiment, the lumen 68 used for magnet delivery can also be used forthe cutting device 36, inserted after the magnet delivery device 40 iswithdrawn from the lumen after delivery of the magnet 42. The stentdelivery device (stent sheath 50) can then be inserted through the lumen68 after withdrawal of the cutting instrument 36. Note that lumen 66 canalternatively be used for the cutting device and/or stent delivery. Ascan be appreciated, the embodiment of FIG. 3B enables a smaller diameterendoscope to be utilized since a single lumen can be used for multiplepurposes. However, the embodiment of FIG. 3A has the advantages ofquicker procedure time and ease of use as the various devices/componentscan be preloaded in the endoscope working channels so the user does notneed to fully withdraw one device and then insert another device throughthe endoscope working channel as in the embodiment of FIG. 3B. Even ifnot preloaded, the instrument of FIG. 3A still saves procedural timebecause one device does not have to be fully removed from the instrumentbefore another device is inserted.

The first magnet 42 is illustrated in FIG. 4. Preferably the magnet 42is delivered in a substantially linear configuration, maintained in thisdelivery configuration (position) by a magnet delivery device (sheath)40 (see FIG. 11). When deployed from the delivery device 40, the magnet42 returns to a curved placement/configuration for placement at thestomach wall. In the embodiment of FIG. 5A, the magnet 42 returns to acircular, 360 degree shape. In the alternate embodiment of FIG. 5B, themagnet 42′ returns from its substantially linear delivery configurationto a C-shaped configuration so that ends 42 a and 42 b are spaced apart.In either embodiment, the magnet 42, 42′ has an opening or space 45, 45′respectively, to receive a cutting device and then a stent as describedin more detail below in conjunction with the method of use. Note themagnet 42, 42′, can be composed of a shape memory material such as anickel titanium alloy, e.g., Nitinol, with a curved memorizedconfiguration to which it returns upon deployment, e.g., a memorizedposition of FIG. 5A or 5B. Other materials are also contemplated.

The second magnet 48 can be the same as the first magnet 42 (or 42′) andits variations described above, and made of the same or alternatematerial as magnet 42 (or 42′). It is contained in the magnet deliverydevice (sheath) 49 (FIG. 13) in a substantially linear deliveryconfiguration (position) and delivered into the bowel for placement atthe bowel wall as described below where it returns to a curvedconfiguration in a similar manner as magnet 42 or 42′ shown in FIG. 5Aor FIG. 5B.

The method of use of the system of the present invention for performinggastric bypass will now be discussed in conjunction with FIGS. 6-20. Itshould be noted that the system can alternatively be used for othersurgical procedures. The first endoscope or endoscopic instrument 10 isinserted transorally into the stomach S so that its distal end 15 isadjacent the stomach wall X as shown in FIG. 7. The second endoscope orendoscopic instrument 12 is inserted through a trocar port into thebowel B with its distal end 13 adjacent the bowel wall Z (FIG. 7). Notethe first endoscope 10 does not necessarily need to be inserted beforethe second endoscope 12, e.g., it could alternatively be inserted afterthe second endoscope 12 is inserted into the bowel B. Additionally, thefirst and second endoscopes 10, 12 can be inserted via other ways intothe stomach and bowel, respectively.

Once positioned in the stomach S, a needle and T-bar delivery sheath 30is advanced from lumen 24 of the endoscope 10 as shown in FIG. 8. Theneedle 32, which carries the T-bar 34, is advanced from sheath 30 by apusher (not shown) to form a puncture through the wall X of the stomachS and the wall Z of the bowel to advance the T-bar 34 into the bowel Bas shown in FIGS. 9 and 10. Sheath 30 can then be retracted or aflexible T-bar connector 33 pulled proximally to pull T-bar 34proximally to engage the inner side of wall Z of the bowel B and to movethe wall Z toward the stomach wall X to approximate the bowel B andstomach S (FIG. 11). The sheath 30 can be retracted within lumen 24.Magnet delivery sheath 40 is then advanced from the lumen 22 of theendoscope 10 (FIG. 11), and a pusher (not shown) within the deliverysheath 40 advances the magnet 42 from the sheath 40. The magnet 42 asshown is retained in a substantially linear delivery position along alongitudinal axis of the delivery sheath 40 for insertion. When themagnet 42 is exposed, it resumes its shape memory position as shown inFIGS. 12 and 13, and when fully exposed assumes the curved circularconfiguration of FIGS. 13 and 5A (or alternatively the C-shape as inFIG. 5B), placed to rest against the internal side of the stomach wallX. As shown, the circular shape of the magnet 42 has an opening 43.

Magnet delivery sheath 49 is then advanced from the lumen 19 of theendoscope 12 (FIG. 13), and a pusher (not shown) within the deliverysheath 49 advances the magnet 48 from the sheath 49. The magnet 42 isretained in a substantially linear delivery position along alongitudinal axis of the delivery sheath 49. When the magnet 48 isexposed, it resumes its shape memory position as shown in FIGS. 14 and15, and when fully exposed assumes the curved circular configuration ofFIGS. 15 and 5A (or alternatively the C-shape like magnet 42′ of FIG.5B), placed to rest against the internal side of the bowel wall Z. Asshown, the circular shape of the magnet 48 has an opening 47. Theattraction forces of the two magnets 42 and 48 maintain the stomach andbowel walls in approximation. Note the T-bar 34 can be removed once themagnets 42 and 48 are in position to maintain the stomach and bowelwalls in approximation due to the magnetic attraction forces.

Once the magnets 42, 48 are in position, cutting instrument 36 isadvanced from the lumen 26 of the endoscope 10 (FIG. 16). The cuttinginstrument 36 is advanced through the openings 43 and 47 of magnets 42,48, respectively, to make an incision through the stomach wall X andbowel wall Z. The cutting instrument 36 is then withdrawn, and stentsheath 50 (FIGS. 17 and 18) is advanced from lumen 28 of endoscope 10. Astent 52 is contained within the stent sheath 50 in a reduced diametercollapsed position. The sheath 50 is inserted through the incisionthrough the stomach wall X, bowel wall Z and into the bowel B. Thesheath 50 is then withdrawn, or the stent 52 exposed from the sheath 50,allowing the stent 52 to expand to a larger diameter expanded secondposition within openings 43, 47 of magnets 42, 48, and leaving the stent52 in position to maintain the opening between the stomach S and bowel Bas shown in FIG. 19. The endoscopic instruments (or endoscopes) 10, 12can then be withdrawn. FIG. 20 shows the stent 52 in position with theendoscopes 10 and 12 removed from the body. A portion of the stomach isthen closed off such as by a stapling instrument (not shown) orsuturing. With the stent 52 in the position of FIG. 20, contents passfrom the stomach into the bowel B through the openings in the stomachwall X and bowel Z.

The procedure provides immediate results as the bypass opening is formedduring the procedure. The surgeon can also see the opening before thepatient is released due to the visualization provided by the endoscopes,thereby increasing efficacy of the procedure.

FIG. 21 provides a flow chart setting forth the method steps of thepresent invention. The steps are as follows: insert a first endoscope(or endoscopic instrument) into the stomach, insert a second endoscope(or endoscopic instrument) into a bowel (although the second endoscopecould alternatively be inserted before the first endoscope), deliver aneedle and T-bar from the first endoscope to advance the needle andT-bar though the stomach and bowel, pull the T-bar proximally toapproximate the bowel and stomach, deploy a first magnet from the firstendoscope into the stomach against the lower wall, deploy a secondmagnet from the second endoscope against a wall of the jejunum (althoughthe second magnet could alternatively be placed (deployed) before thefirst magnet), deploy a cutting instrument from the first endoscope tocut through the opening in the magnets to create an opening between thestomach and bowel, deliver (insert) a stent from the first endoscopeinto the opening between the stomach and bowel (through the openings inthe magnets), remove the first and second endoscopes from the patient,and close off a portion of the stomach. Note the T-bar can be removedafter placement of the first and second magnets.

Note the magnets can be removed after a period of time if desired.

Although the apparatus and method of the subject invention have beendescribed with respect to preferred embodiments, those skilled in theart will readily appreciate that changes and modifications may be madethereto without departing from the spirit and scope of the presentinvention as defined by the appended claims.

1-20. (canceled)
 21. A method of treating obesity in a patient, themethod comprising: inserting a first endoscope into the patient'sstomach; inserting a second endoscope into the patient's bowel;inserting an approximating device into the patient's stomach through thefirst endoscope; puncturing the patient's stomach and the patient'sbowel with the approximating device; retracting the approximating deviceto thereby approximate the patient's bowel and the patient's stomach;inserting a first magnet into the patient's stomach through the firstendoscope; inserting a second magnet into the patient's bowel throughthe second endoscope such that the second magnet is magneticallyconnected to the first magnet through the patient's stomach and thepatient's bowel; inserting a cutting device through the first endoscope;removing stomach and bowel tissue between the first magnet and thesecond magnet to thereby form an opening between the patient's stomachand the patient's bowel; inserting a stent through the first endoscope;and positioning the stent within the opening between the patient'sstomach and the patient's bowel.
 22. The method of claim 21, whereinpuncturing the patient's stomach and the patient's bowel includespassing a needle through the patient's stomach and the patient's bowel.23. The method of claim 22, wherein puncturing the patient's stomach andthe patient's bowel includes positioning an engagement member carried bythe needle in contact with the patient's bowel.
 24. The method of claim23, wherein positioning the engagement member in contact with thepatient's bowel includes orienting a T-bar within the patient's bowelsuch that the T-bar is positioned transversely in relation to theneedle.
 25. The method of claim 23, wherein retracting the approximatingdevice includes pulling the engagement member proximally into contactwith the patient's bowel.
 26. The method of claim 21, wherein insertingthe stent through the first endoscope includes inserting a sheaththrough the first endoscope, the stent being positioned within thesheath.
 27. The method of claim 26, wherein positioning the stent withinthe opening between the patient's stomach and the patient's bowelincludes exposing the stent from the sheath.
 28. The method of claim 21,wherein inserting the first magnet into the patient's stomach includesreconfiguring the first magnet from a generally linear configuration tocurved configuration such that the first magnet defines an opening. 29.The method of claim 28, wherein inserting the second magnet into thepatient's bowel includes reconfiguring the second magnet from agenerally linear configuration to curved configuration such that thesecond magnet defines an opening.
 30. The method of claim 29, whereinremoving the stomach and bowel tissue between the first magnet and thesecond magnet includes passing the cutting device through the opening inthe first magnet and through the opening in the second magnet.
 31. Amethod of treating obesity comprising: inserting a first endoscope intoa first tissue region; inserting a second endoscope into a second tissueregion; puncturing the first tissue region and the second tissue regionusing an approximating device inserted through one of the firstendoscope and the second endoscope; retracting the approximating deviceto thereby position the first tissue region and the second tissue regionin adjacent relation; magnetically connecting the first tissue regionand the second tissue region via insertion of a first magnet into thefirst tissue region through the first endoscope and insertion of asecond magnet into the second tissue region through the secondendoscope; forming an opening between the first tissue region and thesecond tissue region by removing tissue between the first magnet and thesecond magnet using a cutting device inserted through one of the firstendoscope and the second endoscope; and inserting a stent into theopening between the first tissue region and the second tissue regionthrough one of the first endoscope and the second endoscope.
 32. Themethod of claim 31, wherein puncturing the first tissue region and thesecond tissue region includes passing a needle from the first tissueregion into the second tissue region.
 33. The method of claim 32,wherein puncturing the first tissue region and the second tissue regionincludes deploying an engagement member carried by the needle such thatthe engagement member contacts the second tissue region.
 34. The methodof claim 33, wherein retracting the approximating device includespulling the engagement member proximally to thereby pull the secondtissue region into contact with the first tissue region.
 35. The methodof claim 31, wherein forming the opening between the first tissue regionand the second tissue region includes passing the cutting device throughannular openings in the first magnet and the second magnet.
 36. Themethod of claim 31, wherein inserting the stent into the opening betweenthe first tissue region and the second tissue region includes deployingthe stent from a sheath.
 37. A system for treating obesity, the systemcomprising: a) a first endoscope configured to receive a first magnet;b) a second endoscope configured to receive a second magnet; c) a tissueapproximating device configured for movement through the firstendoscope, the tissue approximating device including: a needle; and atissue engagement member carried by the needle; d) a cutting deviceconfigured for movement through the first endoscope; and e) a stentdelivery device configured for movement through the first endoscope, thestent delivery device including: a sheath; and a stent deployablepositioned within the sheath, wherein the first endoscope furtherincludes a plurality of working channels configured to receive the firstmagnet, the tissue approximating device, the cutting device, and thestent delivery device such that the first magnet, the tissueapproximating device, the cutting device, and the stent delivery deviceare each insertable into an internal working space within a patientwithout removing the first endoscope from the patient.
 38. The system ofclaim 37, wherein the first magnet and the second magnet are eachreconfigurable between a first configuration, in which the first magnetand the second magnet are each generally linear, and a secondconfiguration, in which the first magnet and the second magnet are eachgenerally annular.
 39. The system of claim 37, wherein the plurality ofworking channels includes: a first working channel configured to receivethe first magnet; a second working channel configured to receive thetissue approximating device; a third working channel configured toreceive the cutting device; and a fourth working channel configured toreceive the stent delivery device.
 40. The system of claim 37, whereinthe tissue engagement member is repositionable between a first position,in which the tissue engagement member is oriented in generally parallelrelation to the needle, and a second position, in which the tissueengagement member is oriented transversely in relation to the needle.